MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Catalog Number CON-HL-90

Device Problems Device Alarm System (1012); False Alarm (1013); Component Missing (2306); Dent in Material (2526); Device Sensing Problem (2917); Scratched Material (3020); Noise, Audible (3273); Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Information was received that a smiths medical level 1 hotline blood and fluid warmer displays an over temp alarm and has no front cover.Issue was discovered during a pm and no adverse effects were reported.

Manufacturer Narrative

One level 1 hotline was returned for analysis.Upon visual inspection pain chipping, scratches and stains to the enclosure were found; consistent with general wear and tear.The line cord was worn and faded with the enclosure cover missing.The pump was also observed to be noisy.Functional testing was performed by filling the reservoir with water and powering on the unit; high temp reading of 43.4c and the alarm sounded.Based on the evidence, the complaint was confirmed.The fault was found due to the nonfunctioning pcb which is causing the over temp alarm.

• Brand Name: LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8916181
• MDR Text Key: 155064723
• Report Number: 3012307300-2019-04258
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/21/2019
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1